The University of Maryland, Baltimore’s (UMB) Office of Technology Transfer has completed a license agreement with Bali BioSciences LLC, an early-stage company pursuing an unusual, yet clever, strategy to combat disease.

Many current approaches to treating cancer are plagued by significant limitations such as high toxicity and serious side effects, and are systemic in nature, unable to locally target tumors. In addition, despite addressing the primary tumor, metastasis remains one of the most challenging aspects of treating cancer, and is a process that is often unpreventable and uncontrollable.

PVS-30200 utilizes Pervasis’ proprietary implantable material comprised of healthy allogeneic endothelial cells embedded in a polymer matrix that is delivered locally at the time of tumor excision to prevent cell-proliferation, inflammation and angiogenesis, key processes that lead to tumor growth and survival. The well-studied patented technology on which PVS-30200 is founded has a proven safety profile, as demonstrated by data from six clinical studies, and can be administered and targeted locally at the site of the tumor. A novel cell therapy approach, PVS-30200’s use of allogeneic cells, as opposed to autologous cells, enables "off the shelf" administration, eliminating the challenging logistical processes that are involved with the use of autologous cells.

"We plan to present our preclinical findings as well as the PVS-30200 technology to the oncology community as soon as possible; we believe this therapy has the potential to dramatically advance the promise of cell therapy as an innovative and viable treatment paradigm for cancer," said Mr. Chereau.

Pervasis’ Current Clinical Programs

Pervasis is currently conducting a Phase 1/2 clinical study of PVS-10200, an investigational new drug under development to prevent restenosis in patients with peripheral arterial disease who undergo angioplasty and stent placement in the superficial femoral artery. The company’s most advanced program, Vascugel?®, has demonstrated proof of concept and safety in two Phase 2 trials in patients undergoing arteriovenous access procedures for hemodialysis. In 2010, Pervasis announced that it had reached an agreement with the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial of Vascugel under the FDA’s Special Protocol Assessment (SPA) procedure. Through the SPA procedure, FDA formalized its agreement that the design of the Phase 3 trial was acceptable to support a regulatory submission seeking new drug approval.